Our story to date: Wyeth-Ayerst (“the client”) paid DesignWrite, a medical education and communication company (MEC), to write and submit papers to medical journals as part of promotional efforts for Premarin- (conjugated equine estrogens) – and Prempro, which adds medroxyprogeterone acetate to CEE.

The first step is to choose the target journal best suited to the manuscript’s content. …We will then analyze the data and write the manuscript, recruit a suitable well-recognized expert to lend his/her name as author of the document, and secure his/her approval of its content. After the client has reviewed and released the manuscript for submission, DesignWrite will see it through the necessary production stages — creating camera-ready figures and tables and the text according to the journal guidelines — and submit the package (manuscript, art, cover letter, and any required forms and checklists) to the appropriate journal editor… Any revisions requested by the journal will be handled by DesignWrite in conjunction with the client and the author. Should the journal reject the manuscript, DesignWrite will restyle it for submission to another journal within 10 working days.” (1)

From receipt of the internal summary report for a given study, a time frame of one to two months is estimated for manuscript development. The time frame between submission of the draft and the client approval is subject to the client’s internal review. Subsequent revisions, based on client, author, or reviewer comments, are typically addressed in two to three weeks. A period of six to sixteen months is projected for actual publication once the manuscript has been accepted by the journal. The latter time frame is solely a function of individual journal policies.

The following is a typical work flow plan for developing a manuscript for submission to a peer-reviewed journal:

Manuscripts are submitted to peer-reviewed journals directed at the target audiences. Where appropriate, articles dealing with pharmacologic aspects of the drugs will be placed in journals with a pharmacology orientation. These articles could combine updates on study results as well as information comparing the product with other selected therapeutic agents. In addition, they could address trends in treatment and topical issues in patient management.

Journal Supplements

Selected data derived from individual studies could be published together as supplements to target journals within a particular therapeutic specialty. Should the client wish to pursue this publication option, the following guidelines are applicable. A turnaround time of six months is generally adhered to for producing the supplement. This includes all editorial components, including interactions with invited authors, and the target journal. Timing of the publication is ultimately predicated by the individual journal’s supplement schedule. Journal supplements could be published before product launch and be targeted to specific audiences.

Scientific Poster Presentations

At selected medical meetings, lead investigators are able to present the results of their in vitro, preclinical, or clinical studies in an academic atmosphere that many meeting attendees consider desirable. DesignWrite is quite experienced and successful in working with these investigators to ensure that their results are presented in a clear, professional, and impactful manner. Such presentations often represent merely abstracts of studies while others are more thorough. In either event, DesignWrite feels strongly that such poster presentations represent a significant manner of presenting scientific information to target audiences, particularly in preparation for the launch of a product and even postlaunch.